A new model for continuous care of chronic patients - eCare and eLearning for patients with chronic obstructive pulmonary disease (COPD)
| ISRCTN | ISRCTN41424840 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41424840 |
| Secondary identifying numbers | 07/WMW01/53 |
- Submission date
- 14/11/2008
- Registration date
- 23/12/2008
- Last edited
- 07/12/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Keir Lewis
Scientific
Scientific
Respiratory Unit
Prince Phillip Hospital
Hwyel Dda NHS Trust
Llanelli
SA15 3LQ
United Kingdom
| Phone | +44 (0)1554 783133 |
|---|---|
| keir_lewis@hotmail.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | Better Breathing |
| Study hypothesis | Are home electronic monitoring and electronic learning resources feasible and safe for patients with moderate to severe chronic obstructive pulmonary disease (COPD)? |
| Ethics approval(s) | Carmarthenshire LREC gave approval on the 29th October 2007 |
| Condition | Chronic obstructive pulmonary disease (COPD) |
| Intervention | Patients will be randomised into two groups, to either receive standard care or to receive six months telehealth support (doc@HOME), which is an integrated solution for the remote health management of patients with long term conditions and consists of a robust, handheld data collection unit which connects through a standard telephone line at the patient's home to a secure server. doc@HOME is designed to ensure that care follows the patient providing access from anywhere at anytime. Patients will be able to: 1. Complete a system integrated patient tailored questionnaire regarding respiratory status and upload daily 2. Automated daily uploading of physiological measurements obtained from a pulse oximeter and digital thermometer 3. Receive feedback through the system in the form of text/email-like messages between the patient and clinician in response to uploads that can either be automated or targeted according to the review of information received All patients will be required to fill in a series of questionnaires (St George's Respiratory Questionnaire, the Hospital Anxiey and Depression Score questionnaire and the ED-5Q questionnaire) to assess health status and quality of life at five timepoints: baseline, 1 month, 6 months, 7 months and 12 months. Together, these take about 30 minutes to complete. These will be delivered in face-to-face interviews by a member of the Chronic Disease Management Team. The first six months of the study will be the active intervention in which half of the sample will receive the telehealth support, after which there will be six months of passive intervention in order to assess changes in general health status and quality of life. |
| Intervention type | Other |
| Primary outcome measure | Are home electronic monitoring and electronic learning resources feasible and safe for patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)? Measured at baseline, 1 month and 6 months only. |
| Secondary outcome measures | 1. Does home telemedicine reduce respiratory hospital admissions? 2. Does home telemedicine reduce community specialist team visits? 3. Does home telemedicine improve quality of life and mood? 4. Is home telemedicine cost-effective? Measured at all timepoints throughout the trial. |
| Overall study start date | 01/11/2007 |
| Overall study end date | 01/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Participant inclusion criteria | Participants (no gender/age specification) will be recruited for the study from the Prince Phillip and West Wales General Hospital Pulmonary Rehabilitation Scheme. The standard inclusion criteria to be accepted through the scheme for pulmonary rehabilitation is patients who: 1. Feel limited by their chest 2. Have a primary physician 3. Spirometric diagnosis of COPD 4. Are on maximal respiratory medications 5. Have no unstable cardiac disease 6. Have no cognitive impairments In addition, for this project, participants must: 7. Be willing and able to provide informed consent 8. Have a standard telephone line installed in their homes 9. Be willing to have equipment installed in their homes 10. Have attended at least 50% of pulmonary rehabilitation (PR) sessions (aiming for equal baselines) |
| Participant exclusion criteria | 1. No other confounding medical condition to the use of the equipment, e.g. unable to see clearly or touch the screen 2. Not in a nursing or residential institution 3. Participation in any investigational drug trial within one month prior to recruitment 4. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study |
| Recruitment start date | 01/11/2007 |
| Recruitment end date | 01/03/2009 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Respiratory Unit
Llanelli
SA15 3LQ
United Kingdom
SA15 3LQ
United Kingdom
Sponsor information
Informing Healthcare (UK)
Government
Government
c/o Dr Daniel Warm
10/11 Oldfield Road
Bocam Park
Pencoed
CF35 5LJ
United Kingdom
| Phone | +44 (0)1656 678121 |
|---|---|
| daniel.warm@wales.nhs.uk | |
| Website | http://www.wales.nhs.uk/ihc |
"ROR" |
https://ror.org/04a496k07 |
Funders
Funder type
Government
European Community eTEN programme
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2010 | Yes | No |
